utilized in the facility (California Code of Regulations, 2011). Ink used to label packages should be non-toxic and markings should be on the non-porous side of plastic and paper pouches or written on indicator tape placed on the pouch (AAMI, 2017). Section 1005 states that semi-critical instruments, items, and devices shall be pre-cleaned, packaged or wrapped, and sterilized after each use. Methods of sterilization include steam under pressure (autoclaving), chemical vapor, and dry heat. If a semi-critical item is heat sensitive, it shall, at minimum, be processed with high-level disinfection and packaged or wrapped upon completion of the disinfection process. These packages or containers shall remain sealed and shall be stored in a manner so as to prevent contamination, and shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility. If a sterile instrument package is torn, wet, or is otherwise damaged, the instrument should not be used and should be reprocessed and presterilized prior to use (California Code of Regulations, 2011). All high-speed dental handpieces, low-speed handpieces, rotary components, and dental unit attachments such as reusable air/ water syringe tips and ultrasonic scaler tips shall be packaged, labeled, and heat-sterilized in a manner consistent with the same sterilization practices as a semi-critical item. Sterilizer monitoring Proper functioning of the sterilization cycle of all sterilization devices is essential. Although section 1005 only requires the use of weekly biological indicators, sterilizers should be monitored by additional methods, including observations of mechanical indicators and chemical indicators (CDC, 2003; AAMI, 2017). Chemical indicators measure parameters of sterilization such Chemical indicators Chemicals are used to assess physical conditions (e.g., time and temperature) during the sterilization process. Although chemical indicators do not prove that sterilization has been achieved, they confirm that certain essential parameters for sterilization have been met. External indicators applied to the outside of a package (e.g., chemical indicator tape or special markings) change color rapidly when a specific parameter (temperature) is reached, and they verify that the package has been through the sterilization process. Internal chemical indicators verify that the sterilizing agent has penetrated the packaging material and reached the instruments inside. A single-parameter internal chemical indicator provides information regarding only one sterilization parameter (e.g., time or temperature). Multi- parameter internal chemical indicators are designed to react to Biological indicators Biological indicators (spore tests) are the most accurate method for evaluating whether sterilization was achieved. They work by determining if the highly resistant microorganisms (e.g., Geobacillus or Bacillus species) have been destroyed, rather than merely testing the physical and chemical conditions necessary for sterilization. Because these spores are more resistant and present in greater numbers than the other contaminants found on instruments and equipment, an inactivated biological indicator suggests that other potential pathogens in the load have been inactivated. The California Minimum Standards for Infection Control, Section 1005, state, “Proper functioning of the sterilization cycle of all Low-, intermediate-, and high-level disinfection Disinfection is a process that is required for specific clinical surfaces, equipment, prosthetic devices, and other items used in patient care that cannot be heat sterilized. Unlike sterilization, disinfection does not destroy all forms of microbial life, but instead kills various microbes dependent on the concentration and combination of active chemicals. Disinfectants
Non-critical surfaces and patient-care items must be cleaned and disinfected with a Cal/EPA-registered hospital low-level disinfectant that is labeled effective against HBV and HIV. When the item is visibly contaminated with blood or OPIM, a Cal/EPA-registered hospital intermediate-level disinfectant with a tuberculocidal claim must be used (California Code of Regulations, 2011). Cleaning with a suitable product should always precede disinfection. Many disinfectants contain surfactants, making them suitable for both cleaning and disinfection. Always refer to the manufacturer's instructions to determine if the product can be used as a cleaner, the correct contact time, necessary PPE, disposal, and any other important information. Single-use disposable items such as prophylaxis angles, prophylaxis cups and brushes, tips for high-speed evacuators, saliva ejectors, air/water syringe tips, and gloves shall be used for one patient only and discarded. Special dental protocols exist for surgical procedures involving bone or soft tissues; in these instances, Section 1005 stipulates that sterile coolants/irritants must be used and must be delivered using a sterile delivery system (California Code of Regulations, 2011). At the completion of surgery, all contaminated solid waste shall be disposed of according to applicable local, state, and federal environmental standards (California Health and Safety Code, 2017). as heat and length of time, and mechanical indicators are the gauges and digital indicators on the sterilizer that will alert a user to an equipment malfunction. DHCP should regularly evaluate the mechanical aspects of their sterilizers by observing the gauges or displays to assess the time cycle, temperature, and pressure. two or more parameters (e.g., time and temperature, or time, temperature, and the presence of steam) and can provide a more reliable indication that sterilization conditions have been met. The CDC recommends a chemical indicator be placed inside each pack of instruments to be sterilized. If the indicator cannot be seen from the outside, an additional indicator should be placed on the outside of the package (CDC, 2003). The chemical indicator test results that are received when the sterilization cycle is complete can provide an early indication of a problem and when in the process the problem might exist. If the indicators demonstrate that the sterilization cycle was inadequate, the instruments in that load should not be used for patient care. sterilization devices shall be verified at least weekly through the use of a biological indicator (such as a spore test). Test results shall be documented and maintained for 12 months” (California Code of Regulations, 2011). The test must be conducted for each sterilizer in the office, either by sending the test to a commercial lab or testing with an in-office system. The California Code of Regulations requires that these results be available upon inspection if requested. A combination of biological indicators, chemical indicators, and review of the mechanical indicators on the sterilizer should be used by DHCP to closely monitor the effectiveness of their sterilizing systems (CDC, 2003).
must be mixed, stored, and used exactly as directed or their effectiveness may be altered. Disinfectants are categorized as high-, intermediate-, and low-level products, according to the germicidal resistance of the organisms the product is able to inactivate. High-level disinfectants are those that kill viruses, bacteria, fungi, Mycobacterium tuberculosis var. bovis
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